Guidance for Industry 21 CFR Part 11 - Food and Drug Administration
Guidance for Industry 21 CFR Part 11 - Food and Drug Administration
Guidance for Industry 21 CFR Part 11 - Food and Drug Administration
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Draft <strong>Guidance</strong> For <strong>Industry</strong>– Not For Implementation4. References1 <strong>21</strong> <strong>CFR</strong> <strong>Part</strong> <strong>11</strong>; Section <strong>11</strong>.3, Definitions2 American National St<strong>and</strong>ards Institute/The Institute of Electrical <strong>and</strong>Electronics Engineers, Inc. (IEEE) Std 610.12-1990, IEEE St<strong>and</strong>ardGlossary of Software Engineering Terminology3 FDA Center <strong>for</strong> Devices <strong>and</strong> Radiological Health, <strong>Guidance</strong> on Offthe-ShelfSoftware Use in Medical Devices, September 9, 19994 Federal <strong>Food</strong> <strong>Drug</strong> <strong>and</strong> Cosmetic Act, Chapter II, Section 2015 <strong>Food</strong> <strong>and</strong> <strong>Drug</strong> <strong>Administration</strong>, Division of Field Investigations,Office of Regional Operations, Office of Regulatory Affairs, Glossary ofComputerized System <strong>and</strong> Software Development TerminologyDoc ID <strong>Part</strong><strong>11</strong>DraftGlossary_PostRES.doc08/29/016
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